study to evaluate the effect of fx006 on synovial inflammation in patients with oa of the knee

Conditions: Osteoarthritis, Knee

Summary: this is an open-label study assessing the effect of the administration of a single intra-articular (ia) injection of fx006 32 mg on synovial volume in patients with osteoarthritis (oa) of the knee.

this is an open-label study assessing the effect of the administration of a single intra-articular (ia) injection of fx006 32 mg on synovial volume in patients with osteoarthritis (oa) of the knee. the study will be conducted in male and female patients who are ≥ 40 years of age. eligible patients who provide written consent and meet all entry criteria will undergo initial ultrasound examination and mri with contrast of the index knee, and then receive a single ia injection of fx006 administered to the index knee at baseline/day 1. patients will return to the clinic at weeks 6 and 24 for an mri with contrast of the index knee and other assessments. patients must also have a blood sample drawn for estimated glomerular filtration rate (egfr) testing within 30 days prior to the scheduled mris. in addition, a patient questionnaire will be administered and adverse events (aes) and concomitant medication updates will be collected via telephone at weeks 12 and 18.

Eligibility criteria:
inclusion criteria: * written consent to participate in the study * male or female ≥ 40 years of age * body mass index (bmi) ≤ 40 kg/m\^2 * ambulatory and in good general health * willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions * willing to abstain from use of protocol-restricted medications during the study * symptoms associated with oa of the index knee for ≥ 6 months prior to screening (patient self-report is acceptable) * currently meets american college of rheumatology (acr) criteria (clinical and radiological) for oa * kellgren-lawrence (k-l) grade 2 or 3 in the index knee based on x-ray performed during screening (centrally read) exclusion criteria: * any inflammatory arthritis including reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, gout or secondary oa from gout * history of infection or crystal disease in the index knee joint * unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months of screening * surgery or arthroscopy of the index knee within 12 months of screening * ia corticosteroid (investigational or marketed) in any joint within 3 months of screening * ia treatment of the index knee with hyaluronic acid (investigational or marketed) within 6 months of screening * iv or im corticosteroids (investigational or marketed) within 3 months of screening * oral corticosteroids (investigational or marketed) within 1 month of screening * any other ia drug/biologic in the index knee within 6 months of screening or 5 half-lives (whichever is longer) (e.g., platelet rich plasma (prp) injection, stem cells, prolotherapy and amniotic fluid injection) * prior administration of fx006 * egfr results \<40 ml/minute * any contraindication to mri scanning (e.g., presence of certain ferromagnetic foreign bodies or electronic devices including most cardiac pacemakers, claustrophobia) * known hypersensitivity to any form of radiographic contrast * females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study

Keywords: osteoarthritis knee pain intra-articular injection corticosteroid